First novel mycelium ingredient authorised under EU framework opens new growth avenue for Europe’s fermentation-derived food sector

Dutch food ingredients innovator The Protein Brewery has achieved a significant regulatory breakthrough with the European Commission granting authorisation for its flagship mycelium-based ingredient, Fermotein, making it the first novel mycelium ingredient to receive approval under the European Union’s Novel Food framework.

The approval represents a watershed moment for Europe’s alternative protein industry, unlocking commercial opportunities for fermentation-derived ingredients at a time when food companies are seeking sustainable, nutrient-dense protein solutions to meet evolving consumer demand.

Under the Commission’s Implementing Regulation adopted on June 17, 2026, Rhizomucor pusillus mycelium has been formally added to the EU’s list of authorised novel foods. The authorisation follows a positive scientific assessment by the European Food Safety Authority (EFSA) in December 2025 and subsequent approval by the Standing Committee on Plants, Animals, Food and Feed earlier this year.

Six-Year Regulatory Journey Reaches Milestone

The authorisation concludes a regulatory process that began in May 2020, when The Protein Brewery submitted its Novel Food application to the European Commission. As part of the approval, the company has secured five years of exclusive rights to the scientific data supporting the safety assessment, complementing its proprietary and patented fermentation technology.

“We are pleased with the way we worked with the European Commission. They were very open to host us in Brussels for a transparent conversation and discuss important points in the draft regulation together,” said Dr. Yvonne Dommels, Director of Nutrition and Regulatory Affairs at The Protein Brewery. “Today we are proud that we can finally sell Fermotein in our home country and across Europe.” The approval is expected to accelerate commercial adoption of fermentation-derived proteins, a segment increasingly viewed as one of the most promising frontiers in sustainable food innovation.

A New Chapter for Mycelium-Based Nutrition

Fermotein is produced through biomass fermentation using Rhizomucor pusillus, a non-fruiting fungal species related to strains traditionally used in Asian fermented foods. The ingredient offers a compelling nutritional profile, containing approximately 50 percent complete protein, all essential amino acids, and around 30 percent dietary fibre, alongside naturally occurring micronutrients and bioactive compounds.

Its versatility allows application across a broad range of food and nutrition categories, including:

Protein powders and nutritional supplements

Functional beverages

Dairy alternatives

Fortified foods

Nutrition and snack bars

Industry observers view the approval as an important validation of fermentation technologies as Europe seeks to diversify protein sources while reducing the environmental footprint of food production.

Industry Welcomes Regulatory Breakthrough

The decision has been welcomed across the alternative protein ecosystem, although stakeholders also highlighted the lengthy timeline involved. Lea Seyfarth, Policy Manager at Good Food Institute Europe, described the authorisation as an important precedent for future innovation.

“It’s fantastic to see the first approval of a mycoprotein ingredient under the EU’s novel food process, demonstrating that the regulatory system can enable new products to come to market in a way that meets the bloc’s robust safety standards,” Seyfarth said. At the same time, she noted that the six-year approval process underscores the need for regulatory systems to evolve alongside technological innovation, particularly as Europe seeks to remain competitive in the rapidly expanding alternative protein sector.

Commercial Expansion Plans Accelerate

The approval arrives as The Protein Brewery prepares for its next phase of growth. Fermotein is already commercially available in the United States and Singapore. With access to the European market now secured, the company expects demand to accelerate substantially.

The company projects production of approximately 600 metric tonnes from its Breda manufacturing facility in 2027, supported by existing customer commitments across Europe, North America and Asia. Longer term, it aims to expand annual production capacity beyond 2,000 metric tonnes by 2029. According to Thijs Bosch, Chief Executive Officer of The Protein Brewery, the EU approval represents a transformational milestone.

“Europe is our home market and supplying European customers directly from our Dutch factory is a turning point for the company,” Bosch said. “We see strong demand from leading and emerging EU brands looking for a single ingredient that delivers complete protein, fibre and bioactives.”

Significance Beyond a Single Ingredient

Beyond its commercial implications, the approval signals growing regulatory acceptance of next-generation food technologies in Europe. As global food systems confront mounting pressures from population growth, climate change and resource constraints, fermentation-derived proteins are increasingly viewed as a scalable pathway toward more resilient and sustainable nutrition systems.

For The Protein Brewery, the authorisation not only validates six years of regulatory effort but also positions the company at the forefront of a rapidly evolving protein landscape. With Fermotein now cleared for sale across the European Union, the company enters a new phase where regulatory approval gives way to the larger challenge—and opportunity—of scaling production and driving mainstream adoption of mycelium-based nutrition.